The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use was identified.The blade was fractured and separated from the device tip.The teflon pad, handle and contact rings appear to be intact.The jaw crimp was inspected prior to disassembly and was found to be bent and contacting the blade.The device was disassembled to inspect the scalpel rod.Gouges were identified on the blade outside of the cutting area as a result of contact with the shaft assembly.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the reported event could be attributed to: applying improper or unnecessary directional or rotational force to connect instrument to hand piece failure mode: jaws/blade subassembly damage or separation too much force or torque applied to instrument, or grasping/pulling the instructions for use(ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.Do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.The reported event will continue to be monitored through post market surveillance.
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